drugset / Trial / NCT01768468

To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

NCT01768468 ↗

Phase 4 Completed 124 enrolled PMG Pharm Co., Ltd
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and Joins tablet in the treatment of osteoarthritis of the knee.

Timeline

Start
2012-10
Primary completion
2013-06
Completion
2013-09

Outcome

Met primary endpoint

paper lower limit (-8.38) of 95% CI of the difference of VAS improvement between two groups was well above the allowed limit (-10 mm). PMID 26821189 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator JOINS Traditional medicine (herbal / TCM) 200 mg —
Subject LAYLA Traditional medicine (herbal / TCM) 300 mg —

Indications